AccessGUDID - DEVICE: NA (00724995162818)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Quick Connect
Commercial Distribution Status: In Commercial Distribution
Catalog Number: QCC2002
Company Name: STERIS CORPORATION

Primary DI Number: 00724995162818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868205779 *Terms of Use

Device Description: The Quick Connect for Gyrus Acme and Stryker Flexible Endoscopes are used in the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61723	Luminal device flushing tubing set, reusable	A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173256	000
K182827	000
K190104	000
K191343	000
K192929	000
K210737	000
K211607	000
K222615	000
K230582	000
K232914	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ea16de5-2b15-4fc7-b42d-59ee1f0fe2f1
Public Version Date: November 04, 2024
Public Version Number: 11
DI Record Publish Date: May 22, 2019